The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000408684
Ethics application status
Approved
Date submitted
8/04/2014
Date registered
15/04/2014
Date last updated
15/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gum Elastic Bougie vs The Frova Airway Intubating Catheter when using the Glidescope for difficult intubation

Scientific title
Randomised controlled trial of Portex tracheal tube and Frova intubating introducers used with the GlideScope videolaryngoscope in simulated difficult intubation on intubation time (s) and success rate (%) in patients with American Society of Anaesthesiologists (ASA) grade 1 or 2 physical status who required tracheal intubation for elective surgery.
Secondary ID [1] 284404 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult intubation
291623 0
Condition category
Condition code
Anaesthesiology 292001 292001 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: After standardised intravenous induction, cervical manual in-line stabilisation was performed to increase intubation difficulty. Intubation was performed under GlideScope videolaryngoscopy assisted by either the PTTI or the FII.
Intervention code [1] 289143 0
Treatment: Devices
Comparator / control treatment
Two types of bougies are commonly used in our adult anaesthetic practice: the Frova intubating introducer (FII) (Cook Medical Inc., Bloomington, IN, USA) and Portex tracheal tube introducer (PTTI) (Smiths Medical International Ltd, Kent, UK). They facilitate placement of endotracheal tubes with an internal diameter greater than 6 mm. The FII is a single-use 14-French 70-cm-long semi-rigid hollow tube with an angulated tip. With the appropriate adapter, it is also used as a temporary ventilatory device during tracheal tube exchange. The PTTI is a 15-French 60-cm-long reusable solid catheter with an external diameter of 5 mm and an angulated tip . To date, no comparative studies of these devices have been performed in videolaryngoscopy-guided intubation. The aim of this study was to compare the PTTI and FII used with the GlideScope videolaryngoscope in simulated difficult intubation
Control group
Active

Outcomes
Primary outcome [1] 291873 0
The primary outcome criteria were intubation time .

Intubation time (s) was calculated from the time required to obtain a laryngeal view to the time when the upstroke of the capnographic trace was obtained.
Timepoint [1] 291873 0
If the pre-determined time limit of 3 min or oxygen saturation below 94% was reached. The patient was then ventilated by using the bag-mask technique and intubated without manual inline stabilaisation (MILS). This situation was considered to be failed intubation, but the intubation time was included in the subsequent analysis.

primary outcome was assessed on successful completion of intubation
Primary outcome [2] 291874 0
success rate of intubation (%).

correct placement endotracheal intubation confirmed by capnography.
Timepoint [2] 291874 0
Successful completion of intubation confirmed by Capnography trace obtained on the monitor
Secondary outcome [1] 307709 0
Difficulty in intubation was assessed by the operator using both a visual analogue scale (VAS) ranging from 0 (easy) to 100 mm (very difficult) and an ordinal scale ranging from 1 (easy) to 4 (very difficult).
Timepoint [1] 307709 0
The secondary outcome measures were VAS and ordinal scores. Assessed immediately after completion of intubation by the operator.

Difficulty in intubation was assessed by the operator using both a visual analogue scale (VAS) ranging from 0 (easy) to 100 mm (very difficult) and an ordinal scale ranging from 1 (easy) to 4 (very difficult).

Eligibility
Key inclusion criteria
The recruited patients required tracheal intubation for elective surgery and had American Society of Anaesthesiologists (ASA) grade 1 or 2 physical status
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with known or suspected difficult intubation, cervical spine injury, raised intracranial pressure, risk of pulmonary aspiration, and risk of rapid oxygen desaturation were excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opening the opaque sealed envelope just before the intubation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using opaque sealed envelope contained treatment allocation group. The envelope was opened just before intubation for allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The required sample size was calculated by power analysis of the expected intergroup difference in intubation time of 10 s. This duration was considered to represent a clinically meaningful difference that would justify use of one type of bougie over the other. No consensus has been reached on a clinically significant difference in intubation time; other authors chose cut-off points ranging from 5 to 30 s or a 33% reduction in intubation time. Non-parametric analysis was used to compare differences in intubation time and difficulty (Mann–Whitney U-test) with standard type I and type II error rates (alpha = 0.05, Beta = 0.20). Fisher's exact test was used to compare intubation success rates between the groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2303 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 289052 0
Hospital
Name [1] 289052 0
Anaesthetic department research fund, Princess Alexandra Hospital
Address [1] 289052 0
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba , Qld 4102
Country [1] 289052 0
Australia
Primary sponsor type
Individual
Name
Dr Palvannan Sivalingam,
Address
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba , Qld 4102
Country
Australia
Secondary sponsor category [1] 287720 0
None
Name [1] 287720 0
NIL
Address [1] 287720 0
Country [1] 287720 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290848 0
PAH HREC (presently called Metro South HREC)
Ethics committee address [1] 290848 0
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba , Qld 4102
Ethics committee country [1] 290848 0
Australia
Date submitted for ethics approval [1] 290848 0
08/04/2008
Approval date [1] 290848 0
26/05/2010
Ethics approval number [1] 290848 0
2008/057

Summary
Brief summary
Background: A ‘bougie’ may be less traumatic than the GlideScope-specific intubating stylet during videolaryngoscopy-guided intubation, but no comparative studies of bougies have been performed.
Objective: To compare the Portex tracheal tube introducer (PTTI) and Frova intubating introducer (FII) used with the GlideScope videolaryngoscope in simulated difficult intubation.
Trial website
NIL
Trial related presentations / publications
NIL
Public notes
NIL

Contacts
Principal investigator
Name 47578 0
Dr Palvannan Sivalingam
Address 47578 0
Senior Consultant Anaesthetist
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich road
Woolloongabba, Brisbane
Qld 4102
Country 47578 0
Australia
Phone 47578 0
+61 418793209
Fax 47578 0
+61 7 31765102
Email 47578 0
Palvannans@hotmail.com
Contact person for public queries
Name 47579 0
Dr Palvannan Sivalingam
Address 47579 0
Senior Consultant Anaesthetist
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich road
Woolloongabba, Brisbane
Qld 4102
Country 47579 0
Australia
Phone 47579 0
+61 418793209
Fax 47579 0
+61 7 31765102
Email 47579 0
Palvannans@hotmail.com
Contact person for scientific queries
Name 47580 0
Dr Palvannan Sivalingam
Address 47580 0
Senior Consultant Anaesthetist
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich road
Woolloongabba, Brisbane
Qld 4102
Country 47580 0
Australia
Phone 47580 0
+61 418793209
Fax 47580 0
+61 7 31765102
Email 47580 0
Palvannans@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary